Page 165 - Applied Pharmacognosy
P. 165

Types of Chemical markers

       According to European Medicines Agency [EMA] recommendations

• If a herbal medicinal product contains combinations of several

herbal substances or herbal preparations, and if it is not possible to
determine the stability of each active substance, the stability of the
medicinal product should be determined by appropriate fingerprint
chromatograms, appropriate overall methods of assay and physical
and sensory tests or other appropriate tests.

• The appropriateness of the tests shall be justified by the

applicant.
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